BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-ID

    MDR report key: 8267993 · Received January 22, 2019

    Report

    Report Number
    1034569-2019-00032
    Event Type
    Malfunction
    Date Received
    January 22, 2019
    Date of Event
    January 5, 2019
    Report Date
    January 22, 2019
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    UDI-DI
    10888234001140
    PMA / PMN Number
    102707/0.0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMMUCOR LABORATORY TESTED RETENTION PRODUCT ON (B)(4) 2019, WHICH PERFORMED AS EXPECTED. THE IMMUCOR LABORATORY ALSO RECEIVED A BLOOD SAMPLE FROM THE CUSTOMER SITE (NUMBER (B)(6)) AND TESTED IT AGAINST LOT SPECIFIC RETENTION PRODUCT (ID372 AND 221240) ON (B)(4) 2019 WHICH YIELDED A NEGATIVE TESTING OUTCOME. IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD ON (B)(4) 2019 TO ASSESS THE TESTING INSTRUMENT USED AND FOUND THE INSTRUMENT TEST WELL IMAGES IN QUESTION FOR ID372 TO BE VISUALLY NEGATIVE. THE INSTRUMENT TEST WELL IMAGES IN QUESTION FOR R027 ON (B)(4) 2019 WERE VISUALLY WEAKLY POSITIVE. THE CAMERA REPORT WAS ACCEPTABLE AND THE EVENT LOG SHOWED NO ERRORS. AN IMMUCOR FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE TO ASSESS THE TESTING INSTRUMENT USED ON (B)(4) 2019 AND FOUND THAT THE SHAKE HAD TO BE ADJUSTED, WHICH WAS DONE, AND THE WASHER MODULE WAS REPLACED DUE TO DISCOLORED CONNECTIONS. THE INTERNAL IMMUCOR TRACKING RECORD NUMBER IS (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2019, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY IDENTIFICATION OUTCOME WHEN USED ON A GALILEO ECHO INSTRUMENT, WHEN TESTED ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61497 CAPTURE-R READY-ID REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. ID372 10888234001140

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR